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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD012630-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers.
CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.
Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.
All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care + Intervention (Case) | Experimental | Cases will receive the CommunityRx Intervention. |
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| Usual Care (Control) | No Intervention | Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Rx-Hunger (CRx-H) | Other | The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member. |
| Measure | Description | Time Frame |
|---|---|---|
| (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident." | 12 months |
| (Aim 2) Caregiver Satisfaction With Hospital Discharge | Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay. | 7 days post discharge from the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy T Lindau, MD, MPP | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40293738 | Derived | Lindau ST, Makelarski JA, Winslow VA, Abramsohn EM, Anand V, Burnet DL, Fuller CM, Grana M, Miller DC, Ren ES, Waxman E, Wroblewski KE. Low-Intensity Social Care and Child Acute Health Care Utilization: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jun 1;179(6):610-620. doi: 10.1001/jamapediatrics.2025.0484. | |
| 37902777 | Derived | Glasser NJ, Lindau ST, Wroblewski K, Abramsohn EM, Burnet DL, Fuller CM, Miller DC, O'Malley CA, Shiu E, Waxman E, Makelarski JA; CommunityRx-Hunger Collaborators. Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial. JAMA Pediatr. 2023 Dec 1;177(12):1266-1275. doi: 10.1001/jamapediatrics.2023.4596. |
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Prior to the randomized trial, 20 participants were enrolled as part of pre-testing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care + Intervention (Case) | Cases will receive the CommunityRx Intervention. Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member. |
| FG001 | Usual Care (Control) | Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care + Intervention (Case) | Cases will receive the CommunityRx Intervention. Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident." | Analysis was restricted to caregivers who were food insecure at baseline and who completed the self-efficacy measure at 12 month follow-up. | Posted | Count of Participants | Participants | 12 months |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care + Intervention (Case) | Cases will receive the CommunityRx Intervention. Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Abramsohn | University of Chicago | 7738344832 | eabramsohn@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2022 | Dec 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2018 | Nov 22, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2022 | Nov 22, 2024 | ICF_002.pdf |
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Double-Blind randomized controlled trial where the data collectors are blinded to the condition to which the subject has been assigned. The subject is also blinded to the condition they are assigned.
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| 37864258 | Derived | Abramsohn EM, De Ornelas M, Borson S, Frazier CRM, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials. Trials. 2023 Oct 21;24(1):681. doi: 10.1186/s13063-023-07697-z. |
| 36909590 | Derived | Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1. |
| BG001 | Usual Care (Control) | Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Number analyzed in row differs from overall due to missing data and other response. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Usual Care (Control) | Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. |
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| Primary | (Aim 2) Caregiver Satisfaction With Hospital Discharge | Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay. | Caregivers who completed the satisfaction measure at the 1 week follow up are included in the analysis population. | Posted | Mean | Standard Deviation | units on a scale | 7 days post discharge from the hospital |
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| 0 |
| 318 |
| 0 |
| 318 |
| 0 |
| 318 |
| EG001 | Usual Care (Control) | Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. | 0 | 319 | 0 | 319 | 0 | 319 |
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| Unknown or Not Reported |
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